Parkinson's Disease Clinical Trial
— NoMoFAOfficial title:
Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.
NCT number | NCT06406374 |
Other study ID # | 0068862 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 26, 2023 |
Est. completion date | June 10, 2024 |
Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it is now recognized as a multisystemic disease involving not only the central nervous system and presenting with a constellation of motor and non-motor features. While the dopaminergic therapy used to control motor symptoms can lead to the development of motor fluctuations, characterized by wearing-off, ON-OFF phenomenon, delayed-ON, dose failure, and dyskinesias, it has been demonstrated that also many non-motor symptoms can have daily fluctuations, according to the response to dopaminergic therapy. Therefore, non-motor symptoms may fluctuate in parallel with motor symptoms and their relationship to plasma dopamine concentration, although the exact mechanism of non-motor fluctuations (NMF) remains speculative. Non-motor features tend to worsen during disease progression and prove to severely impact the quality of life of patients, sometimes more than motor symptoms. The Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire is a patient-derived and self-administered questionnaire, recently developed and validated by the International Parkinson and Movement Disorder Society (MDS), that identifies and quantifies the severity of static and fluctuating non-motor symptoms in people with PD. The NoMoFA scale is constituted of a total of 27 items investigating several non-motor features, such as fatigue (the most reported), sleepiness, and confusion. Considering the self-administered nature of the scale, patients must understand the questions, and it should be available in the patient's native language. However, the NoMoFa has not yet been translated into the Italian language. Considering that NoMoFA is a relevant scale in the assessment of patients with PD, we believe it is important to perform a translation and cross-cultural adaptation of the NoMoFA questionnaire in Italian, following the scales translation protocol from the international movement disorders society (MDS), and to analyze the reliability and construct validity of the translated scale in Italian patients with PD who experience non-motor fluctuations. The aim of the study is to translate and validate the adapted Italian version of NoMoFA questionnaire.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 10, 2024 |
Est. primary completion date | June 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Diagnosis of idiopathic Parkinson's disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015); - Italian speaker; - Mini-mental state examinations (MMSE) score >25; - Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score>=2; - Stable antiparkinsonian medications for at least three months - Ability to provide informed consent. Exclusion Criteria: - Atypical Parkinsonian syndrome - H&Y>4 - Patients under legal protection |
Country | Name | City | State |
---|---|---|---|
Italy | Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U | Torino | TO |
Lead Sponsor | Collaborator |
---|---|
A.O.U. Città della Salute e della Scienza |
Italy,
Kleiner G, Fernandez HH, Chou KL, Fasano A, Duque KR, Hengartner D, Law A, Margolius A, Poon YY, Saenz Farret M, Saleh P, Vizcarra JA, Stebbins GT, Espay AJ; PSG NoMoFA Study Group. Non-Motor Fluctuations in Parkinson's Disease: Validation of the Non-Motor Fluctuation Assessment Questionnaire. Mov Disord. 2021 Jun;36(6):1392-1400. doi: 10.1002/mds.28507. Epub 2021 Feb 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-motor fluctuations assessment | The aim of this study is to validate an Italian version of NoMoFA scale for the evaluation of non-motor symptoms fluctuations. | The entire project is planned for a duration of 13 months. |
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